Kornimate/medical-research-clean huggingface dataset:
iron and pollen allergy in women

Conditions: Allergy Pollen; Healthy

Summary: iron deficiency and anemia are clearly associated with the onset of allergy and allergic diseases, whereas an improved iron status seems to prevent the onset of allergy in humans. iron-deficiency can be absolute or functional. functional iron-deficiency occurs during immune activation and may be reflective for the hyperactive state of atopic subjects. the investigators plan a prophylactic dietary intervention study in atopic/allergic and non-allergic individuals that transport chelated iron to immune cells. over the course of six months, oral supplementation of placebo or whey protein-bound chelated iron will be given and 1) clinical reactivity 2) iron status and 3) changes in the microflora due to the treatment will be assessed.

there is no state-of-the-art prophylactic treatment for atopy. once allergy develops, allergens should be avoided, and specific allergen immunotherapy applied. the initial cause of the onset of allergy, namely the immune hyperactive state of the atopic subjects, is not addressed at all. the investigators hypothesize that atopy is defined by a mild functional iron deficiency and that improving the iron status of immune cells will decrease the reactivity of these cells. in this prophylactic dietary intervention study oral supplementation of placebo or chelated and whey protein-bound iron will be given over the course of six months to allergic and non-allergic women. changes in 1) the clinical reactivity 2) the iron status and 3) the microflora will be assessed. the study will be the first systematic approach in humans to assess the contribution of iron deficiency to allergy and will be pivotal in supporting the implementation of prophylactic and therapeutic recommendations.

Eligibility criteria:
inclusion criteria: * participants will be healthy premenopausal women over 18 years of age. allergic participants should have been diagnosed with allergic rhinitis against birch and/or grass pollen. exclusion criteria: * subjects with co-morbidities such as diabetes mellitus, disorders of the liver including hemochromatosis or kidney, autoimmune and metabolic diseases or malignancies or who use medications (e.g. antibiotics, ppis) that influence the iron, inflammatory or microbial status will be excluded. further exclusion criteria are pregnancy, lactation, zinc, and iron supplementation and smoking. subjects with a history of major bleeding (including trauma, surgery, other major blood loss) within the last 2 years and blood transfusion within the last 2 years, or with a history of significant breakthrough bleeding will be excluded. volunteers will be asked to cease blood donation at least three months before recruitment. allergics with a history of an allergen-induced anaphylactic shock or with severe, uncontrolled asthma who in the last two years have received allergen immunotherapy or an anti-ige therapy will be excluded.

Keywords: allergy iron-deficiency birch grass
computer-aided diagnosis of ocular diseases based on corneal biomechanics

Conditions: Corneal Ectasia; Corneal Disease; Corneal Astigmatism; Keratoconus; Glaucoma; Open Angle Glaucoma; Normal Tension Glaucoma

Summary: the purpose of this study is the investigation of biomechanical properties of the cornea using computer-aided data analysis. currently, it is known that keratoconus and glaucoma are ocular disease that are associated with biomechanical alterations of the cornea. corneal ectasia, especially keratoconus, is a corneal disease that leads to an irreversible loss of visual acuity while the cornea becomes steeper, thinner and irregular. for these patients, surgical intervention (e.g. corneal cross-linking) is performed, in case of disease progression. in glaucoma, the information about corneal alterations serves in two ways, first, correct measurement of intra ocular pressure (iop); second, early diagnosis of suspects before visual field defects are detectable. especially, the corvis st is an air-puff tonometer that measures intraocular pressure, corneal thickness (cct) as well as dynamic corneal response (dcr) parameters. most of the dcr parameters are affected by iop and cct: therefore, algorithm are needed to determine parameters without impact of iop and cct that are describe the biomechanical properties of the cornea.

in this study, an eye twin based on finite element modeling is used to measure advanced properties of corneal biomechanics. raw data of corvis st measurement are exported from the device and imported into the model. the outcome of these calculations are merged together and are compared to further clinical findings (e. g. corneal topography and tomography, axial eye length). further information were obtained: age, sex, refraction, family history, known duration of disease, previous ocular surgery, systemic diseases, systemic and topical medication; biomicroscopy, anterior optical coherence tomography (oct), scheimpflug-based tomography (pentacam), biomechanical assessment (ocular response analyzer and corneal visualization with the scheimpflug technology), optical biometry, confocal microscopy, endothelium cell count.

Eligibility criteria:
inclusion criteria: * corneal ectasia (keratoconus) or ectasia suspect * glaucoma (primary open angle glaucoma and normal tension glaucoma) or glaucoma suspect exclusion criteria: * age under 18 years * pregnancy

Keywords: cornea ectasia keratoconus finite element modelling computer-aided data analysis glaucoma corneal biomechanics
ketamine for multiple sclerosis fatigue

Conditions: Multiple Sclerosis Fatigue

Summary: the proposed study is a single-center, phase ii, randomized, double-blind, parallel-group, active-placebo-controlled trial of intravenous low-dose ketamine in patients with ms fatigue.


Eligibility criteria:
inclusion criteria: * subject must be a man or woman, 18 to 65 years of age, inclusive. * subject must be medically stable based on physical examination, medical history, and vital signs * subject must meet mcdonald 2017 diagnostic criteria for multiple sclerosis based on the pi review of the medical records * subject must complain from fatigue as one of their main symptoms and have a screening mfis score equal or higher than the cutoff based on gender, age, and education displayed in table-226 * subject must be ambulatory (able to walk at least 20 feet using bilateral assistance) * subject must have internet and email access and ability to use a computer or tablet or smartphone * subjects that are currently taking medication for alleviating fatigue (such as amantadine, modafinil and armodafinil, and amphetamine-like psychostimulants) at screening are eligible to participate unless the medication is one of the disallowed therapies (table 3). subjects taking a fatigue medication at the screening visit must have been receiving a stable dose for at least four weeks before the screening visit and be willing to continue the medication at the same dose for the duration of the study. exclusion criteria: * bdi-ii score of more than 29 (indicating severe depression) * having a known clear cause for secondary fatigue, such as untreated sleep apnea, untreated hypothyroidism, chronic liver disease, history of moderate to severe anemia (hemoglobin concentration of less than 9 gr/dl in men or less than 8 gr/dl in women). * neurodegenerative disorders other than relapsing or progressive ms * breastfeeding or pregnant * history of coronary artery disease or congestive heart failure * uncontrolled hypertension at screening (history of high blood pressure and screening systolic blood pressure \>160 or diastolic blood pressure\>100) * history of severe liver disease, including cirrhosis * terminal medical conditions * currently treated for active malignancy * alcohol or substance abuse in the past year (except marijuana or other cannabinoids) * a history of intolerance or allergic or anaphylactic reaction to ketamine or midazolam * clinically unstable medical or psychiatric disorders that require acute treatment as determined by the pi * history of severe or untreated coronary artery disease or history of congestive heart failure * history of prior ischemic or hemorrhagic stroke and cerebral vascular aneurysms. * history of recurrent seizures or epilepsy * taking any disallowed therapy(ies), as noted in the protocol.
regional citrate anticoagulation in plasma exchange treatment

Conditions: Focal Segmental Glomerulosclerosis; Guillain-Barre Syndrome

Summary: the investigators want to compare the efficacy of plasma exchange treatment with using two different citrates ( 4% and 15% ) as anticoagulants in plasma exchange treatment. the efficacy of plasma exchange treatment is better with using 15% trisodium citrate as anticoagulant during the plasma exchange procedure.

to compare the elimination rate of immunoglobulins in plasma exchange treatment by using two differently concentrated citrates for anticoagulation during plasma exchange procedure. at the same time we want to compare acid-base , electrolyte status and anticoagulation protocol in two citrate groups.

Eligibility criteria:
inclusion criteria: * patients who need plasma exchange treatment * human albumins as a replacement fluid exclusion criteria: * anemia hb less than 90

Keywords: citrate anticoagulation plasma exchange efficacy
unobtrusive monitoring of affective symptoms and cognition using keyboard dynamics (unmasck)

Conditions: Mood Disorders; Major Depressive Disorder; Bipolar Disorder I; Bipolar Disorder II; Persistent Depressive Disorder (Dysthymia); Cyclothymia

Summary: mood disorders are associated with significant financial and health costs for the united states, partially due to cognitive problems in these patients that can worsen disease course and impair treatment response. this study proposes to use smartphone-based technology to monitor cognitive problems in patients with mood disorders by linking brain network changes with predicted worsening of mood symptoms. the proposed study will provide evidence for using smartphone-based passive sensing as a cost-effective way to predict illness course and treatment response.


Eligibility criteria:
inclusion criteria: * 25-50 years, as age-related declines in brain connectivity occur starting around 40-45 years of age (49-51); * participants must meet criteria for one of the following disorders according to diagnostic and statistical manual of mental disorders-5 criteria (52): major depressive disorder (mdd), persistent depressive disorder (pdd), bipolar disorder (bd) type i/type ii, cyclothymia. to ensure adequate representation across diagnostic categories (including controls), the investigators will cap enrollment of major mood disorders (mdd, bd type i/ii) to 50%, pdd and cyclothymia to 25% and recruit a healthy comparison group to comprise the remaining 25% of the sample. * own a biaffect-compatible smartphone. exclusion criteria: * active suicidal ideation as determined by the columbia suicide severity rating scale (c-ssrs)(50), suicide attempt in the last 3 months * severe cognitive impairment secondary to a neurological disorder (mild cognitive impairment, neurocognitive disorders, traumatic brain injury, developmental delay) * active moderate or severe alcohol and/or substance use disorders; * major medical or neurologic illness that would interfere with protocol adherence and/or interpretation of findings; and * presence of contraindications to mri. * pregnancy (positive pregnancy test), trying to become pregnant, or lactation.
a phase iia study to assess the safety, efficacy, and pharmacokinetics of subcutaneously administered pegcetacoplan (apl-2) in subjects with pnh

Conditions: PNH

Summary: this is a phase iia, open-label, multiple dose, study in patients with pnh who have not received eculizumab (soliris ®) in the past. a single cohort of subjects is planned for evaluation.


Eligibility criteria:
inclusion criteria: * at least 18 years old (inclusive) * diagnosed with pnh (white blood cell (wbc) clone \>10%) * lactose dehydrogenase (ld) ≥2 times the upper limit of normal * screening ferritin ≥ normal and total iron binding capacity (tibc) \< lln based on central lab reference ranges. if a subject is receiving iron supplements at screening, the investigator must ensure that his/her dose has been stable for 8 weeks prior to enrolment and must be maintained throughout the study * last transfusion within 12 months prior to screening * platelet count of \>30,000/mm3 at the screening visit * absolute neutrophil count \>500/ mm3 at the screening visit * women of child-bearing potential (wocbp) must have a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study * males must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study * vaccination against neisseria meningitides types a, c, w, y and b, streptococcus pneumoniae and haemophilus influenzae type b (hib) either within 2 years prior to day 1 dosing, or within 14 days after starting treatment with pegcetacoplan. unless documented evidence exists that subjects are non-responders to vaccination as evidenced by titers or display titer levels within acceptable local limits * willing and able to give informed consent exclusion criteria: * prior eculizumab (soliris®) treatment * active bacterial infection * hereditary complement deficiency * history of bone marrow transplantation * concurrent severe aplastic anemia (saa), defined as currently receiving immunosuppressive therapy for saa including but not limited to cyclosporin a, tacrolimus, mycophenolate mofetil or anti-thymocyte globulin * participation in any other investigational drug trial or exposure to another investigational agent, device or procedure within 30 days * evidence of qtcf prolongation defined as \>450 ms for males and \>470 ms for females at screening * breast-feeding women * history of meningococcal disease

Keywords: pnh paroxysmal nocturnal hemoglobinuria complement inhibitor anemia hemoglobinuria hemolysis hematologic diseases extravascular hemolysis (evh) intravascular hemolysis (ivh) c3 inhibitor
pilot rct local gentamicin for open tibial fractures in tanzania

Conditions: Open Tibia Fracture

Summary: local application of antibiotics directly to the traumatic wound is a promising strategy for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. this pilot study aims to assess feasibility of a randomized controlled trial to measure the effect of locally applied gentamicin on risk of infection for open tibial fractures in tanzania. if proven effective, local gentamicin would be a highly cost-effective strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries.

this pilot study is being conducted in dar es salaam, tanzania to assess the feasibility of a masked, placebo-controlled, randomized trial to compare local gentamicin injection to saline injection in open tibial shaft fractures. the study will enroll patients within 1 week of injury. the active or placebo agent will be administered during the initial surgical debridement based on a web-based randomization tool. patients will be followed for 1 year after surgery to assess for the occurrence of fracture-related infection (fri), a consensus definition of infection after open fracture or insertion of internal fixation to treat fracture. additional clinical and economic endpoints will also be measured. depending on the outcome of the feasibility study, we may undertake a definitive trial to test the effectiveness of local gentamicin to prevent fri. if proven effective, local gentamicin would impact the clinical care of open fracture patients both in tanzania and likely in high-income settings as well. these data will also deepen the understanding of the clinical and economic impact of fri in open fracture populations.

Eligibility criteria:
inclusion criteria: 1. male or female patients age 18 or older 2. diagnosis of an acute open tibial shaft fracture meeting the following criteria: 1. ao/ota type 42 2. primarily closable wound 3. type i, ii, or iiia gustilo- anderson (ga) classification exclusion criteria: 1. time from injury to presentation \> 48 hours 2. time from injury to surgery \>7 days 3. history of aminoglycoside allergy 4. ga iiib or iiic open fractures 5. bilateral open tibial fractures 6. severe brain (gcs\<12) or spinal cord injury 7. severe vascular injury 8. sustained severe burns (\>10% total body surface area (tbsa) or \>5% tbsa with full thickness or circumferential injury) 9. pathologic fracture 10. history of active limb infection, ipsilaterally
contrast enhanced spectral mammography (cesm) study

Conditions: Breast Cancer

Summary: the aim of this study is to determine if the addition of contrast enhanced spectral mammography (cesm) to standard diagnostic imaging, results in a decision regarding patient management - discharge, follow-up, surgery or treatment - being made sooner than it would if the patient had followed the standard course of investigations and review.

women with suspicious breast lesions following mammography and ultrasound will be eligible for the study. those who consent to participate will be randomised either to receive contrast enhanced spectral mammography (cesm) in addition to standard care or to receive standard care alone. women randomised to receive cesm will undergo the procedure either during the same visit or if necessary on another date within a week. any additional suspicious lesions detected by cesm will be biopsied along with the original lesion either under ultrasound or x-ray guidance. biopsy of suspicious lesions is standard care and not part of the research protocol. those randomised to receive standard care will undergo ultrasound or x-ray guided biopsy of any suspicious lesion identified by ultrasound or mammography. results of all biopsies will be discussed at the next multidisciplinary (mdt) meeting where a treatment decision (conservation surgery, mastectomy or neoadjuvent therapy) will be made for those with confirmed disease. mri will be performed on appropriate women in line with standard practice. additional disease detected by mri will be biopsied, either under ultrasound or mri guidance, if this will influence patient management. the results from these cases will be discussed at the next mdt meeting. for those women in either arm of the study with benign biopsy results standard care will be followed. a proforma will be used to record patient pathway, biopsy results and mdt patient management decisions for each case. for women who received both cesm and mri, a retrospective review of these images will be made in order to compare diagnostic accuracy. images from each imaging modality will be read by a different reader for each case. cesm images will be read without the knowledge of mri results and vice versa. a proforma will be completed by readers to record findings.

Eligibility criteria:
inclusion criteria: * be willing and able to give written informed consent for participation in the study. * have a lesion of suspicion 3, 4 or 5 following mammography and ultrasound. exclusion criteria: * known or suspected pregnancybreast implant * previous breast cancer * known renal impairment * history of anaphylactoid or anaphylactic reaction to any contrast media * contrast media within 24 hours prior to cesm * commencement of neo-adjuvant chemotherapy, hormone treatment, radiotherapy or surgery for this episode

Keywords: contrast enhanced spectral mammography breast cancer diagnosis patient management
antibodies and immunity after vaccination of recovered patients with covid-19 and long covid-19 symptoms

Conditions: Long COVID-19

Summary: we investigated the association between immune system responsibilities in long covid patients and full recovery patients.

this retrospective cohort study compared immunogenicity post covid-19 between individuals (aged 18-65 years and had confirmed sars-cov-2 infection from january to may 2022 ) with residual long covid-19 symptoms (lc) and ones with full recovery (full) related to pathophysiology, immunology and clinical consequence.

Eligibility criteria:
inclusion criteria: * long covid group; at longer than 1-month post covid-19 based the presence of one of the three following symptoms: fatigue/myalgia, breathlessness, and anorexia * full recovery group; patients with asymptomatic symptoms * post covid-19 they had not received any additional covid vaccine exclusion criteria: * people who received additional vaccination after leaving quarantine before the day of the immunization test * pregnant patients, * people who had a history of allergic reactions after covid-19 vaccination or any drugs

Keywords: long covid-19 antibody responsibility immunogenicity
feasibility of an early palliative care intervention for metastatic cancer patients. a phase 2 study.

Conditions: Lung Cancer; Mesothelioma; Pancreas Cancer; Gastric Cancer

Summary: the objective of this phase 2 study is to evaluate the feasibility of an early palliative care intervention for metastatic cancer patients. feasibility will be assessed in terms of percentage of patients that accept the proposal of the early palliative care intervention and that effectively start to be followed in the palliative care out-patient clinic. the study will be performed in a consecutive series of newly diagnosed patients affected by lung cancer (nsclc or sclc, stage iiib, iv), mesothelioma (stage ii, iv), pancreas (stage iv), stomach (stage iiib-iv).


Eligibility criteria:
inclusion criteria: * patients within 8 weeks of cancer diagnosis confirmed by histology or cytology * lung cancer (nsclc or sclc) stage iiib-iv or mesothelioma stage iii-iv or pancreas cancer stage iv, or gastric cancer stage iiib-iv * age more than 18 years * performance status (ecog) ≤ 2; * ability to read, understand and fill-in the questionnaires * written informed consent to the study exclusion criteria: * any chemotherapy, radiotherapy or ormonotherapy for any tumour in the past 12 months

Keywords: cancer early palliative care feasibility